(100 days)
Not Found
No
The document describes a blood glucose meter and insulin pump remote control. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a remote controller of a Symphony Pump for insulin delivery, and a therapeutic device is an apparatus, technology, or procedure used to treat a disease or condition. The delivery of insulin is a form of treatment for diabetes.
Yes
The device is described as an "in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations)" and is intended for use "as an aid to monitor the effectiveness of diabetes control." However, it explicitly states, "It should not be used for the diagnosis of diabetes." While it aids in monitoring, it is not for initial diagnosis. Given the common understanding of a "diagnostic device" as one that helps diagnose a disease, and its explicit exclusion for diagnosis of diabetes, it falls into a gray area. But given it provides quantitative measurement of glucose, which is a diagnostic indicator, it can be considered a diagnostic device for monitoring purposes.
No
The device description explicitly states it is a "reusable handheld-battery operated device" that functions as a blood glucose meter and a remote controller, indicating it is a physical hardware device, not software only.
Yes, based on the provided text, the Symphony Meter Remote is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "...and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting..." The phrase "in vitro diagnostic use" directly identifies it as an IVD.
- Function as a Blood Glucose Meter: The "Device Description" states that the device is "designed to function both as an in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations)..." This further confirms its IVD function.
- Measurement of Glucose in Blood: The primary function described is the "quantitative measurement of glucose in fresh capillary whole blood," which is a classic example of an in vitro diagnostic test.
While the device also has a function as a remote control for an insulin pump, its intended use and design explicitly include the in vitro diagnostic function of measuring blood glucose.
N/A
Intended Use / Indications for Use
The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.
Product codes
LZG, CGA, JJK, FMK
Device Description
The Symphony Meter Remote is designed to function both as an in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations) and as a remote controller of a Symphony Pump for insulin delivery through an infusion set placed subcutaneously.
The Symphony Meter Remote is a reusable handheld-battery operated device supplied clean and non-sterile to primarily function as a stand-alone blood glucose meter. With user activation of RF communication between a specific Symphony Meter Remote and specific Symphony Pump, the Symphony Meter Remote also becomes a remote controller of certain features of the Symphony Pump. When paired through radio frequency (RF) communication the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings.
The Symphony Meter Remote incorporates other design features that utilize glucose test data, insulin delivery data, and information important to overall diabetes management, as well as provide interface capability with a personal computer (PC) via data management software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, forearm or palm.
Indicated Patient Age Range
It should not be used for...testing of newborns.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance evaluations, both bench and clinical, of the Symphony Meter Remote were completed and did not raise any new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
K082570 f. lot 2
Symphony Meter Remote
Traditional 510(k)
510(k) Summary
| SUBMITTER: | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035-6312 | DEC 17 2008 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | Contact: Martha Murari, Ph.D., RAC
Sr. Regulatory Submissions Specialist | |
| DEVICE NAME: | Symphony Meter Remote | |
| COMMON OR USUAL NAME: | Remote Controller and Accessory
for Insulin Infusion Pump | |
| DEVICE CLASSIFICATION: | Classification of device used as Remote Controller and
Accessory for Insulin Infusion Pump is as follows:
• Class II per 21 CFR § 880.5725, Pump, Infusion,
Insulin (product code LZG) | |
| | Classifications of devices used with Glucose Test
System of the Symphony Meter Remote are as follows:
• Class II, OneTouch® Ultra® Test Strips,
per 21 CFR § 862.1345 (product code CGA)
• Class I, OneTouch® Ultra® Control Solution,
per 21 CFR § 862.1660 (product code JJK)
• Class I (exempt) OneTouch® Lancing Device
with OneTouch® AST ClearCap™ and OneTouch®
UltraSoft® Sterile Lancet. per 21 CFR § 878.4800
(product code FMK) | |
| PREDICATE DEVICES: | The predicate device is as follows:
•Symphony Meter Remote previously filed as part
of the Symphony Glucose Management System
(K080639) | |
DEVICE DESCRIPTION:
The Symphony Meter Remote is designed to function both as an in vitro diagnostic device for self-monitoring blood glucose (measure blood glucose concentrations) and as a remote controller of a Symphony Pump for insulin delivery through an infusion set placed subcutaneously.
The Symphony Meter Remote is a reusable handheld-battery operated device supplied clean and non-sterile to primarily function as a stand-alone blood glucose meter. With user activation of RF communication between a specific Symphony Meter Remote and specific Symphony Pump, the Symphony Meter Remote also becomes a remote controller of certain features of the Symphony Pump. When paired through radio frequency (RF) communication
LifeScan, Inc.
1
08257i p. 2 of 2
the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings.
The Symphony Meter Remote incorporates other design features that utilize glucose test data, insulin delivery data, and information important to overall diabetes management, as well as provide interface capability with a personal computer (PC) via data management software.
INTENDED USE/ INDICATIONS FOR USE:
The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.
SUBSTANTIAL EQUIVALENCE:
As part of the Symphony Glucose Management System (K080639, cleared June 24, 2008), the Symphony Meter Remote remains the same as submitted with the system and remains substantially equivalent to the device submitted therein.
RESULTS OF PERFORMANCE EVALUATION:
Performance evaluations, both bench and clinical, of the Symphony Meter Remote were completed and did not raise any new issues of safety and effectiveness.
CONCLUSION:
The Symphony Meter Remote is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" encircling the eagle. The text is arranged in a circular pattern around the eagle symbol. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Martha Murari, Ph.D., RAC Senior Regulatory submissions Specialist LifeScan, Incorporated 1000 Gibraltar Drive Milpitas, California 95035
DEC 1 7 2008
Re: K082590
Trade/Device Name: Symphony Meter Remote Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG. CGA Dated: November 24, 2008 Received: November 25, 2008
Dear Dr. Murari:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Dr. Murari
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu S. Lin, Ph.D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082590
Device Name: Symphony Meter Remote
Indications for Use:
The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-
CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Anten the
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K482594